Coated VICRYL JJ41GRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031044135), received between Dec 18, 2018 and Mar 28, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON 28-FEB-2025 AND SUTURE WAS USED. UPON OPENING THE SUTURE, A HAIR WAS NOTICED ENTANGLED WITHIN THE SUTURE. A NEW BOX WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. NO PATIENT CONSEQUENCES WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719827 ↗
• MalfunctionJul 5, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING USE, A SUTURE ON OUR 0 SUTURE 27" POPOFFS WOULD PULL OFF THE SWAGE WAY TOO EASILY. SHE SAID THERE WOULD BE VERY LITTLE TENSION AND THE NEEDLE POPPED OFF. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680255 ↗
• MalfunctionSep 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF PREMATURELY. THIS HAPPENED FOUR TIMES IN THE CASE. A DIFFERENT PACK WITH DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492032 ↗
• MalfunctionSep 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF PREMATURELY. THIS HAPPENED FOUR TIMES IN THE CASE. A DIFFERENT PACK WITH DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492022 ↗
• MalfunctionSep 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF PREMATURELY. THIS HAPPENED FOUR TIMES IN THE CASE. A DIFFERENT PACK WITH DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492019 ↗
• MalfunctionSep 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF PREMATURELY. THIS HAPPENED FOUR TIMES IN THE CASE. A DIFFERENT PACK WITH DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491987 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES POPPED OFF THE SUTURES TOO EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366765 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES POPPED OFF THE SUTURES TOO EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366764 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES POPPED OFF THE SUTURES TOO EASILY. A NEW BOX WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366763 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES POPPED OFF THE SUTURES TOO EASILY. A NEW BOX WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366762 ↗
• MalfunctionDec 3, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AND UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF PRIOR TO TIME INTENDED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407454 ↗
• MalfunctionDec 3, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AND UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF PRIOR TO TIME INTENDED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407451 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175530 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175526 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175522 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175521 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175515 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175514 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175510 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175475 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE OR STAFF OPENED THE STERILE SUTURE PACKET AND A DIFFERENT TYPE OF SUTURE AND NEEDLE WAS INSIDE. SUTURE FROM A DIFFERENT LOT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175473 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc